DOUBLE-BLIND STUDY OF PREDNICARBATE VERSUS FLUOCORTIN BUTYL ESTER IN ATOPIC DERMATITIS

Patients and Methods This parallel-group, double-blind trial compared the efficacy and tolerability of topical prednicarbate, 0.25% ointment, with that of fluocortin butyl ester, 0.75% ointment. The trial included 79 outpatients at three participating centers. All patients had a diagnosis of atopic dermatitis on the basis of Hanifin and Rajka's criteria.¹ Other inclusion criteria were: age ≥ 18 years and stability or worsening of the condition for at least 1 week in the current episode. Patients were required to have been treatment-free for minimum periods of: 7 days if previously treated with other topical corticosteroids; 1 month if previously treated with systemic corticosteroids; 3 days if previously treated with shortacting antihistamines; 2 months if previously treated with astemizole. Exclusion criteria were: severe incapacitating dermatitis; infectious processes or association with other skin changes; need for the concomitant administration of antihistamines or antimicrobials; serious concurrent illness. Women not using adequate contraception were also excluded. A thin layer of topical prednicarbate (N = 42) or fluocortin butyl ester (N = 37) was applied to the affected area of skin twice daily, without occlusion. The duration of treatment was set at 21 days, but it could be interrupted earlier, at the discretion of the investigator, on the grounds of total disappearance of the condition, inefficacy, or the appearance of any adverse reaction. A daily application of an emollient oil and/or a cleaning or emollient aqueous cream could be used at the investigator's discretion. At the start of treatment and at 4, 7, 14, and 21 days, each of the following features was rated on a scale of 0 to 3 (0; absent, 1: mild, 2: moderate, 3: severe): pruritus; excoriations; erythema; scaling; lichenification; vesiculation; hyper-keratosis. On the basis of these scores, the overall efficacy of treatment was rated as: improvement > improvement of > 50 to 75%; improvement of > 25 to 50%; improvement < 25%; no improvement; worsening. If the treatment ended before 21 days, owing to either cure or inefficacy, the score for the last evaluation was used for all subsequent followup points. At the end of treatment the investigator and the patient rated treatment as excellent, good, fair, or poor. Cosmetic acceptance by the patient was evaluated in the same terms.